IgE-Mediated Food AllergyPhase 3NCT07768371
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
A Phase 3 study testing Remibrutinib in people with IgE-Mediated Food Allergy and Peanut Allergy, run by Novartis Pharmaceuticals at 18 sites in United States.
Trial summary
The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin E (IgE)- mediated allergy in comparison to placebo. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy
- What is being tested?
- Remibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 576 participants
- Where
- 18 sitesUnited States
- Study dates
- 27 Aug 2026to 31 Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent and/or assent (where applicable) must be obtained prior to study participation. Participant (and parent/legal guardian for adolescents) must be able to understand and provide informed consent and assent, as applicable. If a minor participant providing assent reaches the age of legal majority (as defined by local law), he/she must be re-consented (ICF) at the next study visit.
- Male or female participants who are 12 to 65 years of age, inclusive, at the time of signing informed consent/assent.
- Positive allergen-specific (peanut, milk, or egg), IgE (≥ 0.35 kUA/L) at Screening Visit 1.
- Positive Skin Prick Testing (SPT) for peanut, milk, or egg at Screening Visit 1. This is defined as the average diameter (longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to the negative control.
- A positive DBPCFC at baseline (Screening Visit 2), defined as the occurrence of dose-limiting symptoms at a single dose:
- ≤ 100 mg of peanut allergen protein
- ≤ 300 mg for milk or egg allergen protein
- Participants must be able and willing to participate in the DBPCFC and must be willing to continue avoiding exposure to peanut, milk (cooked and uncooked), or egg (cooked and uncooked) and any other foods that they are allergic to throughout this study.
Who cannot join
- Previous use of remibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors.
- History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.
- Hypersensitivity or intolerance to any of the matrix components used within the material for the DBPCFC.
- Any occurrence of dose-limiting symptoms against placebo allergen at baseline DBPCFC (Screening Visit Part 1 and/or Part 2).
- Medical examination, medical conditions or laboratory findings that, in the opinion of the investigator, renders the participant unsuitable for the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Childrens Healthcare Of Atlanta
Atlanta, Georgia, 30329
Ashley Dulson, Ashley.Dulson@choa.org
Brian Vickery
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Gledson Hanelt, ghanelt1@jhu.edu
Robert Wood
- Recruiting
AllerVie Clinical Research-Homewood
Birmingham, Alabama, 35209
Esther Patterson Lange, +1 205 871 9661, elange@allervie.com
Weily Soong
- Recruiting
Childrens Hosp Boston Dept of Heme
Boston, Massachusetts, 02115
Sidney Wang, +1 617 355 7700, sidney.wang@childrens.harvard.edu
Rima Rachid
- Recruiting
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, 20815
Amy Tran, iaaresearchatran@gmail.com
Huamin Henry Li
- Recruiting
Asthma and Allergy Associates P C
Colorado Springs, Colorado, 80907
Sneha Tata, +1 719 473 8330, STata@aacos.com
Daniel Soteres
- Recruiting
Western Sky Medical Research
El Paso, Texas, 79924
Laura Herrera, lherrera@westernskymed.com
Todd Funkhouser
- Recruiting
Arkansas Childrens Hosp Rsch Inst
Little Rock, Arkansas, 72202
Erin Thomas, +1 501 978 6413, ThomasES@archildrens.org
Amy Scurlock
- Recruiting
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
Vivienne An, +1 310 966 9050, viviennean@calallergy.com
Ricardo Tan
- Recruiting
Northwell Health
New York, New York, 10028
Aaqil Ali, +1 516 622 5064, aali27@northwell.edu
Sherry Farzan
- Recruiting
Sneeze Wheeze Itch Asso LLC
Normal, Illinois, 61761
Stephanie Oliver, stephanieoliver@asthma2.com
Dareen D Siri
- Recruiting
National Allergy and Asthma Research LLS
North Charleston, South Carolina, 29420
Faye Singleton, +1 843 820 1036, fsingleton@nationalallergyandent.com
Patricia Gerber
- Recruiting
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, 60305
Emily Rodriguez, emily@asthmaallergycenterofchicago.com
Rachna Shah
- Recruiting
Impact Medical - Circuit Clinical
Riverdale, New Jersey, 07457
Melba Ventura, mventura@circuitclinical.com
Jeffrey Weiss
- Recruiting
Allergy Associates of Utah
Sandy City, Utah, 84093
Rylee Roper, +1 801 263 8700, rylee.roper@utahallergies.com
Andrew M Smith
- Recruiting
Medical Resch of Arizona-Div of Allergy Asthma and Immunology
Scottsdale, Arizona, 85251
Jasmine Hernandez, +1 480 889 6313, jas@medicalresearchaz.com
Michael E Manning
- Recruiting
Montefiore Health System
The Bronx, New York, 10461
Patricia Pallo, ppallor@montefiore.org
Punita Ponda
- Recruiting
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197
Diana Grigoryan, +1 734 434 3007, dgrigoryan@annarborallergy.com
Jeffrey G Leflein
About this study
Official title: A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy and Safety of Remibrutinib (LOU064) in Adult and Adolescent Participants With IgE-mediated Food Allergy
The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin E (IgE)- mediated allergy in comparison to placebo.
Read the detailed description
This study is a Phase III, 52-week, multi-center, placebo controlled pivotal study to evaluate the efficacy and safety of remibrutinib compared to placebo in adolescent and adult participants with peanut, milk, or egg IgE-mediated allergy.
This study will be conducted in 4 Sub-studies: Sub-study 1 to evaluate response to peanut allergen at Week 24, Sub-study 2 to evaluate response to milk allergen at Week 24, Sub-study 3 to evaluate response to egg allergen at Week 24, and Sub-study 4 to evaluate response to peanut or milk, or egg allergen at Week 4.
Treatment period 1: Participants will receive one of the two treatment groups, double-blind remibrutinib or placebo, for a period up to 24 weeks for Sub-studies 1, 2, and 3, and up to 4 weeks for Sub-study 4.
Treatment period 2: For all Sub-studies, the open label period starts at Week 24, except for Sub-study 4, where the open label period starts at Week 4. Participants from each Sub-study will continue in the study and receive, or initiate, active open label remibrutinib until Week 52.
Following completion of the treatment period 2, eligible participants may enroll in a separate open-label post-trial access study and receive remibrutinib to evaluate long-term treatment effects. Participants who do not enroll in the post-trial access study will enter a 4-week safety follow-up period off treatment, during which adverse events will be monitored.
- Being tested
- Remibrutinib, Placebo
- Keywords
- IgE-mediated food allergy,, peanut allergy,, milk allergy,, egg allergy,, remibrutinib
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemibrutinibDrug
Also called LOU064
Oral administration of remibrutinib.
PlaceboDrug
Oral administration of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1- LOU064 | Experimental | Participants with peanut allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. Receives: Drug: Remibrutinib; Drug: Placebo |
| Sub-study 1- Placebo | Placebo comparator | Participants with peanut allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. Receives: Drug: Placebo |
| Sub-study 2- LOU064 | Experimental | Participants with cow's milk allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. Receives: Drug: Remibrutinib; Drug: Placebo |
| Sub-study 2- Placebo | Placebo comparator | Participants with cow's milk allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. Receives: Drug: Placebo |
| Sub-study 3- LOU064 | Experimental | Participants with hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. Receives: Drug: Remibrutinib; Drug: Placebo |
| Sub-study 3- Placebo | Placebo comparator | Participants with hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. Receives: Drug: Placebo |
| Sub-study 4- LOU064 | Experimental | Participants with peanut, cow's milk, and hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52. Receives: Drug: Remibrutinib; Drug: Placebo |
| Sub-study 4- Placebo | Placebo comparator | Participants with peanut, cow's milk, and hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-study 1: Number of participants achieving response status (tolerated at least 600 mg of peanut protein)
Response status is defined as tolerating an oral dose of at least 600 mg peanut protein (1044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Measured: Week 24
Sub-study 2: Number of participants achieving response status (tolerated at least 1000 mg of milk protein)
Response status is defined as tolerating an oral dose of at least 1000 mg milk protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Measured: Week 24
Sub-study 3: Number of participants achieving response status (tolerated at least 1000 mg of egg protein)
Response status is defined as tolerating an oral dose of at least 1000 mg egg protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Measured: Week 24
Secondary outcomes (16)
Sub-study 1: Number of participants achieving response status (tolerated at least 1000 mg of peanut protein)
Response status is defined as tolerating an oral dose of at least 1000 mg peanut protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Measured: Week 24
Sub-study 1: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of peanut protein
Change from baseline in log10-transformed maximum tolerated single dose of peanut protein without dose-limiting symptoms during the DBPCFC.
Measured: Baseline and Week 24
Sub-study 2: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of milk protein
Change from baseline in log10-transformed maximum tolerated single dose of milk protein without dose-limiting symptoms during the DBPCFC.
Measured: Baseline and Week 24
Sub-study 3: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of egg protein
Change from baseline in log10-transformed maximum tolerated single dose of egg protein without dose-limiting symptoms during the DBPCFC.
Measured: Baseline and Week 24
Sub-study 1: Number of participants by Maximum Symptom Severity During Peanut Protein Challenge
Maximum severity of symptoms occurring at any challenge dose up to and including 1000 mg peanut protein during the DBPCFC. Symptom severity is categorized as None, Mild, Moderate, or Severe.
Measured: Week 24
Sub-study 2: Number of participants by Maximum Symptom Severity During Milk Protein Challenge
Maximum severity of symptoms occurring at any challenge dose up to and including 1000 mg milk protein during the DBPCFC. Symptom severity is categorized as None, Mild, Moderate, or Severe.
Measured: Week 24
Sub-study 3: Number of participants by Maximum Symptom Severity During Egg Protein Challenge
Maximum severity of symptoms occurring at any challenge dose up to and including 1000 mg egg protein during the DBPCFC. Symptom severity is categorized as None, Mild, Moderate, or Severe.
Measured: Week 24
Sub-study 1: Number of participants achieving response status (tolerated at least 3000 mg of peanut protein)
Response status is defined as tolerating an oral dose of 3000 mg peanut protein (5044 mg cumulative tolerated dose) without dose-limiting symptoms during the DBPCFC.
Measured: Week 24
Sub-study 2: Number of participants achieving response status (tolerated at least 3000 mg of milk protein)
Response status is defined as tolerating an oral dose of 3000 mg milk protein (5044 mg cumulative tolerated dose) without dose-limiting symptoms during the DBPCFC.
Measured: Week 24
Sub-study 3: Number of participants achieving response status (tolerated at least 3000 mg of egg protein)
Response status is defined as tolerating an oral dose of 3000 mg egg protein (5044 mg cumulative tolerated dose) without dose-limiting symptoms during the DBPCFC.
Measured: Week 24
Sub-study 4: Number of participants achieving combined response status (tolerated at least 600 mg of peanut protein, or at least 1000 mg of milk or egg protein)
Combined response status is defined as tolerating at least 600 mg peanut protein (1044 mg cumulative tolerated dose) or at least 1000 mg milk or egg protein (2044 mg cumulative tolerated dose), as applicable, without dose-limiting symptoms during the DBPCFC.
Measured: Week 4
Sub-study 4: Number of participants achieving combined response status (tolerated at least 1000 mg of peanut, milk or egg protein)
Combined response status is defined as tolerating at least 1000 mg peanut, milk, or egg protein, as applicable (2044 mg cumulative tolerated dose), without dose-limiting symptoms during the DBPCFC.
Measured: Week 4
Sub-study 4: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose
Combined change from baseline in log10-transformed maximum tolerated single dose of peanut, milk, or egg protein, as applicable, without dose-limiting symptoms during the DBPCFC.
Measured: Baseline and Week 4
Sub-study 4: Number of participants by Maximum Symptom Severity During Food Challenge
Combined maximum severity of symptoms occurring at any challenge dose up to and including 1000 mg peanut, milk, or egg protein, as applicable, during the DBPCFC. Symptom severity is categorized as None, Mild, Moderate, or Severe.
Measured: Week 4
Sub-study 4: Number of participants achieving combined response status (tolerated at least 3000 mg of peanut, milk or egg protein)
Combined response status is defined as tolerating an oral dose of 3000 mg peanut, milk, or egg protein, as applicable (5044 mg cumulative tolerated dose), without dose-limiting symptoms during the DBPCFC.
Measured: Week 4
Sub-studies 1, 2, 3 and 4: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: Up to 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start27 Aug 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgE-Mediated Food AllergyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768371
- Sponsor's protocol ID
- CLOU064I12301
- Other IDs
- 2024-519159-28-00
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com